[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR822.9]

[Page 159-160]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 822--POSTMARKET SURVEILLANCE--Table of Contents
 
                 Subpart C--Postmarket Surveillance Plan
 
Sec. 822.9  What must I include in my submission?

    Your submission must include the following:
    (a) Organizational/administrative information:
    (1) Your name and address;
    (2) Generic and trade names of your device;
    (3) Name and address of the contact person for the submission;
    (4) Premarket application/submission numbers for your device;
    (5) Table of contents identifying the page numbers for each section 
of the submission;
    (6) Description of the device (this may be incorporated by reference 
to the appropriate premarket application/submission);

[[Page 160]]

    (7) Product codes and a list of all relevant model numbers; and
    (8) Indications for use and claims for the device;
    (b) Postmarket surveillance plan;
    (c) Designated person information;
    (1) Name, address, and telephone number; and
    (2) Experience and qualifications.